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Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites

NCT04301661 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2023-01-09

No results posted yet for this study

Summary

This study will evaluate the intracellular pharmacokinetics and platelet effects of abacavir (ABC), lamivudine (3TC), tenofovir alafenamide (TAF), and emtricitabine (FTC) in persons living with HIV that are receiving these medications as part of standard HIV care.

Participants remaining on ABC/3TC- or TAF/FTC-containing therapy will be on study for 4 weeks, and will have two visits: a screening visit and one short PK visit consisting of a single blood draw at week 4.

Participants switching from their ABC/3TC-containing therapy will be on study for 3 weeks, and will have nine visits: a screening visit and 8 short PK visits consisting of a single blood draw at Day 0, 1, 3, 7, 10, 14, 18, and 21.

Conditions

Interventions

OTHER

Blood collection

Blood will be collected from participants at defined time points during the study to measure drug levels and assess platelet activity.

DRUG

Abacavir/lamivudine

Participants who are already taking abacavir/lamivudine as part of standard HIV care will continue taking their therapy.

DRUG

Tenofovir alafenamide/emtricitabine

Participants who are already taking tenofovir alafenamide/emtricitabine as part of standard HIV care will continue taking their therapy.

DRUG

Switch

Participants who are planning to switch from abacavir/lamivudine as part of standard HIV care will change therapy to per the discretion of their HIV provider.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kristina M Brooks, PharmD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2021-12-17
Completion
2021-12-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301661 on ClinicalTrials.gov